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HRT Compliance Attorneys

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Guiding Hormone Therapy Clinics and Platforms

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Hormone replacement therapy (HRT) is one of the fastest-growing segments of modern healthcare and one of the most legally complex. Clinics, digital health platforms, and compounding pharmacy partners operating in the HRT space face overlapping FDA oversight, state prescribing laws, compounding pharmacy regulations, and telehealth compliance requirements. A misstep in any of these areas can result in enforcement action, licensing consequences, or significant liability.

At LumaLex Law, we provide dedicated compliance counsel to hormone therapy providers navigating this landscape. Reach out to our team to make sure you are compliant.

The Legal Complexity of Hormone Replacement Therapy

The demand for HRT services has expanded rapidly across both traditional clinical settings and direct-to-consumer digital health platforms, bringing increased scrutiny from the FDA, state medical boards, and pharmacy regulators. 

LumaLex Law works with hormone therapy businesses at every stage, from pre-launch compliance structuring to ongoing regulatory support as operations scale. Our attorneys understand the clinical context behind HRT and translate that into practical, defensible compliance frameworks.

Why HRT Is a High-Scrutiny Healthcare Category

HRT sits at the intersection of several regulatory frameworks that do not always align. The FDA regulates hormone drug products and compounding pharmacies. State medical boards govern prescribing authority. State pharmacy boards regulate dispensing. And telehealth regulations, which vary significantly by state, govern how HRT can be prescribed digitally. The combination of these overlapping frameworks makes this a category that demands careful, proactive legal attention.

The Difference Between FDA-Approved and Compounded HRT

FDA-approved hormone therapies carry specific labeling, dosing, and indication requirements. Compounded hormone therapies are prepared by licensed pharmacies for individual patients based on a practitioner’s prescription, allowing for customized dosing but operating under a more constrained regulatory framework. Understanding which pathway governs your clinic’s protocols is foundational to a legally sound HRT practice.

Regulatory Gray Zones in Bioidentical and Blended Hormones

The FDA has consistently stated that the term “bioidentical” carries no recognized regulatory meaning. Clinics and platforms that market HRT services using bioidentical language without understanding the compliance implications face real enforcement and liability risk. LumaLex Law helps clients structure their clinical communications in ways that are accurate, compliant, and defensible.

HRT Compliance Services We Provide

At LumaLex Law, our services for hormone therapy clients include:

  • FDA compounding compliance review for 503A and 503B pharmacy relationships
  • State prescribing law analysis and multi-state expansion planning
  • Telehealth prescribing compliance
  • Informed consent drafting and review
  • Marketing and advertising compliance review
  • Scope of practice analysis for mid-level providers
  • Compounding pharmacy partnership agreements
  • Ongoing regulatory monitoring

Who We Advise in the Hormone Therapy Space

LumaLex Law advises hormone therapy clinics and wellness practices, direct-to-consumer digital health platforms, compounding pharmacies, medical spas incorporating hormone therapy, startup and growth-stage companies entering the HRT market, and private equity groups conducting diligence on HRT platform acquisitions.

Federal and State Laws That Govern HRT Operations

At the federal level, key frameworks include the Federal Food, Drug, and Cosmetic Act and its 503A and 503B compounding provisions, DEA regulations for controlled substances such as testosterone, and FTC guidelines on health claims in marketing. 

State-level requirements add further challenges, including:

  • Medical practice acts defining prescribing authority.
  • Pharmacy board rules for compounding and dispensing.
  • Telehealth prescribing regulations.
  • Scope-of-practice laws for non-physician providers.

Multi-state HRT platforms face heightened challenges from jurisdictional variations, requiring robust compliance frameworks to manage differing standards across states.

High-Risk Compliance Areas for HRT Clinics

Areas of elevated risk include whether adequate patient evaluation is documented before therapy begins, whether compounding pharmacy partners are operating within 503A or 503B requirements, whether marketing language around bioidentical claims and outcomes is defensible, whether informed consent documentation meets state law requirements, and whether telehealth prescribing practices align with what each patient’s state actually permits.

How LumaLex Law Supports Long-Term HRT Compliance

Compliance is not a one-time project. The FDA periodically issues new compounding guidance, state telehealth and prescribing rules continue to evolve, and enforcement activity in the HRT space is ongoing. LumaLex Law supports clients on a long-term basis through regulatory monitoring, periodic compliance audits, policy updates as regulations change, and proactive guidance when clients consider new services or markets. 

Learn more about our firm or explore our full range of legal services.

Work With an HRT Compliance Attorney Who Understands the Industry

At LumaLex Law, we understand how HRT clinics operate and the laws surrounding them. Contact LumaLex Law today to speak with an HRT compliance attorney.

 

FAQ

Not all hormone therapies involve controlled substances, but some do. Testosterone is a Schedule III controlled substance, meaning clinics prescribing testosterone replacement must work with DEA-registered practitioners and comply with applicable prescribing and recordkeeping requirements. Estrogen and progesterone are not scheduled and do not carry DEA obligations.

Generally yes, under certain conditions, but the rules are nuanced. A 503A pharmacy's ability to ship to patients in a given state depends on that state pharmacy board's rules on receiving compounded medications from out-of-state pharmacies. Clinics relying on 503A partnerships for fulfillment should have those relationships reviewed to confirm compliance.

A sufficient informed consent form should address the nature of the therapy, known risks and side effects, available alternatives including FDA-approved options, limitations of compounded preparations where applicable, monitoring and follow-up requirements, and the patient's right to withdraw consent. State-specific and telehealth-specific disclosure requirements may add additional obligations.

It depends on the state. NPs have full practice authority in some states and operate under supervision or collaborative agreement requirements in others. Multi-state platforms relying on NP prescribers need a jurisdiction-by-jurisdiction analysis to ensure every prescribing arrangement is compliant where the patient is located.

Ian Horowitz

Ian Horowitz

Of-Counsel
States Licensed: FL

Mr. Horowitz focuses his practice on estate planning, taxation, and business related matters, with advanced proficiency in estate, gift, federal income, and generation-skipping transfer taxation. His extensive knowledge in these areas enables him to craft tailored strategies that optimize tax efficiency and safeguard his clients’ assets. From crafting straightforward wills to designing complex domestic and foreign trusts, his commitment to preserving wealth and ensuring asset protection is unwavering.

In addition to his prowess in estate planning, Mr. Horowitz serves as a trusted advisor to businesses of all sizes from formation to sale assisting with drafting purchase and sale agreements, limited liability operating agreements, or other corporate documents. His counsel on entity formation and tax-efficient structures empowers entrepreneurs and corporations to make informed decisions that drive growth and prosperity.

Mr. Horowitz possesses a wealth of experience in international tax matters. He offers invaluable guidance to foreign clients navigating inbound business and real estate transactions in the United States. He is also recognized for his efficiency in helping individuals become bona fide residents of Puerto Rico under IRC Section 937. This specialized knowledge in tax strategies related to Puerto Rico’s unique tax laws positions him as a sought-after advisor for those seeking to take advantage of the favorable tax incentives offered by Puerto Rico.

Aggeliki Psonis

Aggeliki Psonis

Associate
States Licensed: NY, NJ. MA

A graduate of Boston University, with a JD from CUNY law school, Aggeliki focuses her practice on real estate transactions, estate planning and administration, business law and general litigation. She has extensive experience representing buyers, sellers, investors and business owners based in New York and internationally.

Aggeliki is admitted in the states of New York, New Jersey and Massachusetts, as well as in the Eastern and Southern Districts of New York. She is also a licensed Real Estate broker. She is a proud member of the Inspiring Women in Law League (IWILL) and the Hellenic Lawyers Association. She speaks fluent Greek and conversational French and Spanish. Aside from lawyering, she enjoys being a radio producer and performing artist.

Dallas Robinson, Of-Counsel

Dallas Robinson

Of-Counsel
States Licensed: FL

 

Dallas Robinson is an AV Preeminent-rated trial attorney who has dedicated his practice to representing injured people throughout Florida. Dallas has litigated and tried many different types of personal injury cases in numerous courthouses and venues in Florida. Dallas believes in prosecuting personal injury cases in a professional and aggressive manner, and has a clear track record of success in obtaining great financial compensation for his clients either through verdicts or settlements. Many lawyers advertise ‘trial experience,’ but have actually never seen the inside of a courtroom. Dallas has spent his entire career in the courtroom and litigating cases. This gives Dallas the real and true experience that it takes to strike fear in the hearts of insurance companies and obtain top financial compensation for his injured clients.

 

Dallas grew up in South Florida and attended Boston University where he played quarterback and defensive back for Boston University’s football team. Dallas graduated in 4 years with bachelor degrees in Classical Civilizations and History. He went straight to law school and attended University of Miami (FL) School of Law. Dallas graduated in 2002 with a Juris Doctorate degree and immediately passed the Florida Bar.

 

Dallas began his legal career representing businesses and insurance companies in workers’ compensation and personal injury cases. This gave him unique insight into exactly how insurance companies work and how they value cases. After achieving a high level of success in litigating these cases, Dallas moved on to representing the injured. Since that time, Dallas has obtained tens of millions of dollars in compensation for his clients through settlements and trial verdicts. Dallas is a member of the Multi-Million Dollar Advocates Forum which is an association of attorneys who have won seven-figure verdicts and settlements on behalf of their clients. This group is one of the most prestigious organizations for trial lawyers in the United States as fewer than 1% of U.S. lawyers have qualified as members.

 

In addition to great results for his clients, Dallas has also gained the respect of his peers for his ethics, ability, and professionalism. Dallas has received the highest level of distinction of an AV ® rated attorney by Martindale-Hubbell, which recognizes Dallas as possessing “Very High-Preeminent” legal ability with “Very High” ethical standards.

Yisroel Szpigiel, Of-Counsel

Yisroel Szpigiel

Of-Counsel States Licensed: NY, NJ  
Yisroel Szpigiel is a NY/NJ corporate attorney focused on outside general counsel and commercial transactions. With nearly a decade of experience managing law firms, he represents entrepreneurs, investors, and some of New York’s largest real estate developers in matters ranging across the full business lifecycle– from entity formation and early stage growth to day-to-day commercial contracting to complex financings, acquisitions, and strategic exits. He has closed over $100 million in transactions and is known for practical, business-first legal guidance that protects clients while keeping deals moving. 
 
Since joining LumaLex Law as Managing Partner January 2025, Yisroel has grown the firms Commercial Transactional and Real Estate Practices, and has started the firms MSO practice, focusing on private equity healthcare rollups. Yisroel is best known as a “problem solver”, with the ability to turn complex problems into workable solutions. He was twice named as a Super Lawyers New York Rising Star in 2024 and 2025, in the practice areas of Business Law, Real Estate, Mergers and Acquisitions, and Plaintiff’s Personal Injury.

In addition to his work with LumaLex Law and serving as trusted outside counsel to businesses in a wide range of industries, he has been recognized by community leaders with citations and awards. Yisroel earned his undergraduate degree from Rutgers University and his J.D. from Hofstra University School of Law, where he later returned as an adjunct professor. Outside the office, he enjoys golf, pickleball, and traveling with his wife and three children. 
Tom Dean | Of-Counsel

Tom Dean

Of-Counsel 
States Licensed: AZ

 

Tom Dean has been an attorney advocate for nationwide cannabis policy reform for over 25 years. As Legal Director for the National Organization for the Reform of Marijuana Laws (NORML) he initiated, managed, and litigated important cannabis related cases of national importance to the cannabis industry/community. In that capacity, he also coordinated the efforts of the NORML Legal Committee (lifetime member) and NORML Amicus Committee (former chair) in key cases throughout the U.S.  In 2015 the organization recognized his successful advocacy by inducting him into the NORML Distinguished Counsel’s Circle. He remains an active member of the NORML Legal Committee.

In 2016, Tom received the President’s Commendation award from the Arizona Attorneys for Criminal Justice (AACJ). In 2020, Tom received a Lifetime Achievement Award from the Errl Cup, a medical marijuana event producer which includes Arizona’s premier cannabis awards festival (30,000 attendees this year).

In 2021, Tom received Mikel Weiser Lifetime Achievement Award from Arizona’s Marijuana Industry Trade Association (MITA). Most recently, in 2023, Tom was honored by NORML with its Al Horn Award, which the organization awards to an attorney each year to in “recognition of a lifetime of ceaseless work to advance the cause of justice” in cannabis law.

Tom was a founding member of the Arizona Cannabis Bar Association (ACBA), an organization that seeks to educate lawyers and the public of the many unique aspects of cannabis law and emerging cannabis related areas of practice. He continues to serve on the board of ACBA. Outside of his practice, Tom enjoys, among other things, presenting at cannabis related seminars and conferences for lawyers and the public.

Josh Sanderlin | Of Counsel

Joshua Sanderlin

Of Counsel
States Licensed: MD, D.C.

Joshua Sanderlin is an experienced cannabis attorney and government affairs expert barred in Maryland and the District of Columbia. He has worked in the cannabis industry since 2013. At that time, he was an attorney and lobbyist at a large, global law firm. His experience working with clients in the earliest legal cannabis market in the U.S. sparked his interest in the field and motivated him to leave big law for the world of cannabis.

Since then, he has served as a lawyer and consultant to clients working in markets across the country, including seven states and the District of Columbia. His experience has given him a wide breadth of knowledge on issues touching the industry and, just as importantly, expanded his network to include experts from all across the industry. Having worked on cannabis issues in a variety of settings, Joshua understands that the industry is best served by specialized services.

Edgar J. Asebey | Of Counsel

Edgar J. Asebey

Of Counsel
States Licensed: FL, D.C.

 

Edgar J. Asebey is a regulatory and transactional attorney with over two decades of experience in federal regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement and cosmetics companies. Since 2015, he has been working on Cannabis-related matters and transactions and since 2018 he has provide regulatory compliance, business transactional, venture finance and international trade services to hemp/CBD companies. Edgar brings a wealth of knowledge and over 20 years of experience to life science, Cannabis and hemp/CBD clients who require novel solutions to complex issues.

Edgar practices before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Customs and Border Protection (CBP), Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC), representing client companies on regulatory compliance, product approval/registration and FDA enforcement defense matters. He also assists clients with international and domestic business transactions, IP licensing, venture finance, trademark protection and import/export matters.

Edgar studied molecular biology at the University of Chicago and spent 5 years working in molecular biology research laboratories at the University of Chicago and the University of Illinois.  Early in his career he served as a Patent and Licensing Advisor to the Natural Products Branch of the National Cancer Institute at the National Institutes of Health (NIH).  He founded and served as president of Andes Pharmaceuticals, Inc., a natural products drug discovery company, from 1994 to 2000 and has served as in-house counsel to two life sciences companies. Most recently he was an equity partner in the Health Care & Life Sciences Practice Group at Jones Day. Edgar is currently a partner at Keller Asebey Life Science Law, PLLC.

While Edgar holds licenses to practice law in Florida and Washington, D.C. he can represent clients on federal regulatory matters in all 50 states.  He is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.

Dan Miller Head-Shot | Of-Counsel

Dan Miller

Of-Counsel
States Licensed: CA

Dan Miller, Esq., with over 15 years of experience in cannabis law and a growing expertise in psychedelics, is a staunch advocate for honoring both traditional and evolving regulated uses of these substances. A Vermont Law School alumnus (Class of 1998), he holds a J.D. and a Master’s in Environmental Law and Policy.

Before his foray into the world of entheogenic medicines, Dan honed his skills as a trial attorney with a focus on both criminal and civil cases. His passion for and in-depth understanding of cannabis and psychedelic substances redirected his career path, leading him to develop a niche practice area that has since become his hallmark.

Dan’s role in the cannabis industry is not just as a lawyer, but as a partner in his clients’ endeavors. He oversees all aspects of business development, from structural planning and licensing to adapting to dynamic legal landscapes. His strategic insights have been key in securing licenses, operational planning, and facilitating interstate business growth.

Dan continues to serve as outside general counsel for various businesses, leveraging his litigation background to offer comprehensive legal advice.

As the legal landscape continues to evolve, Dan Miller remains a steadfast and knowledgeable advocate, committed to bridging the gap between traditional use and modern regulatory frameworks in the world of cannabis and psychedelics.

States Licensed: CA

Christina Jaramillo | Junior Associate

Christina Jaramillo

Junior Associate
States Licensed: FL, CA

Christina Jaramillo is an Associate Attorney at LumaLex Law and an active member of The Florida Bar. Christina’s primary focus has been in the practice area of business transactions. Christina has legal experience drafting and reviewing various sales and services agreements, completing entity filings and EIN applications, drafting corporate governance documents and business plans, preparing franchise disclosure documents, drafting and reviewing commercial and residential lease agreements, assisting with mergers and acquisitions, preparing demand letters, working on estate plans and probate matters, and trademarks. Prior to joining LumaLex Law, Christina led the estate planning department at The Law For All, P.A.

Christina is the daughter of two Latinx immigrants, the youngest of five siblings, and the first member of her immediate family to graduate from college. In 2017, after just three short years on campus, Christina received her Bachelor of Science in Political Science, magna cum laude, from Florida State University, where she also minored in Economics. Christina received her Juris Doctor, magna cum laude, from the University of Miami School of Law in 2020.

While attending the University of Miami School of Law, Christina received several honors: Christina was nominated to serve as one of two Articles & Comments Editors for the University of Miami International and Comparative Law Review; Christina was a recipient of the Dean’s Certificate of Achievement Award, which is awarded to the top one or two students in the course, in Legal Communications & Research II; and Christina made the Dean’s List twice.

During her time in law school, Christina served as a Fellow and Blog Editor for the Professional Responsibility and Ethics Program (PREP), an intern for the Human Rights Clinic, and a Civil Procedure Dean’s Fellow. Christina was active on campus and engaged in her community because she understood the value in connecting with those around her and serving the needs of her community, which remains true today.

In her free time, Christina can be found at her local comic book shop or vegan bakery. Christina loves to read, stay up to date on popular television shows and movies, watch soccer, and occasionally jog.

Andy Sick | Partner

Andy Sick

Partner
States Licensed: NY, NJ, MI, CT

Andy Sick has been advising businesses, startups, and entrepreneurs for nearly 15 years. He assists clients through every stage of the business life cycle from incorporation and initial growth phases, to maturity with ongoing general counsel services including regulatory compliance and critical commercial transactions, and dissolution. Licensed to practice in New York, New Jersey, and Connecticut, Andy is the attorney responsible for the firm’s practice in these states.

At Mr. Cannabis Law, Andy represents various cannabis-related businesses on such matters as corporate structuring, licensing, and financing. He navigates clients through the constantly changing sea of cannabis rules and regulations. Andy handles marijuana license applications, business plans, and operating procedures for dispensaries, cultivators, nurseries, manufacturers, distributors, wholesalers, delivery services, and testing facilities. For the firm’s hemp industry clients, Andy helps obtain hemp licenses and maintain compliance with federal and state regulations. In the psychedelic space, Andy has served as a legal advisor to numerous non-profits, companies, and organizations including such groups as Decriminalize Nature and the Native American Church.

Andy began his legal career at boutique law firms serving as outside general counsel to businesses and representing clients in complex commercial litigation. Whether representing a three-person video game startup or a multinational spent nuclear fuel storage company, Andy worked directly with company presidents and other executives to develop and implement corporate legal strategies. Subsequently, he founded several startups, including a legal technology company that adapted artificial intelligence and virtual reality for use in the law. In addition to working with Mr. Cannabis Law, Andy has his own law firm, Sick Legal, which provides business and commercial transactional services to a range of clients.

During law school, Andy worked at the U.S. Justice Department’s Office of Consumer Litigation, the U.S. Attorney’s Office for the Northern District of New York, and for President Joe Biden when he served on the U.S. Senate Judiciary Committee

Andy is responsible for firm operations in New York, New Jersey, Michigan, and Connecticut 

Amanda Barton | Partner

Amanda Barton

Partner
States Licensed: FL

Amanda Barton is an active member of the Florida Bar and is admitted to practice in all U.S. District Courts and U.S. Bankruptcy Courts within the state of Florida.  Amanda has over ten years of legal experience handling complex corporate matters, with a strong focus on corporate governance, corporate finance, and regulatory compliance.  As someone who loves written language, Amanda excels in drafting and negotiating a vast array of legal documents.

Prior to joining LumaLex Law, Amanda had unique legal opportunities that have made her a well-versed, seasoned transactional business attorney.  Previously, she led the transactional department at The Law for All, P.A., where she assisted business clients with strategic business structuring, mergers and acquisitions, asset protection, business succession planning, and contract drafting, including companies involved in the cannabis and hemp industry.  She served as senior in-house counsel for an alternative financing company, where she built a legal department that leveraged technology, data analysis, and innovative resolution and recovery strategies.  Amanda also served as in-house counsel to a private investment firm, where she handled all in-house transactions with a concentration in Debtor-in-Possession financing for Chapter 11 debtors, secured lending transactions, fund management, and various aspects of municipal bond financing.

Amanda currently volunteers her time to serve as the President of the Broward County chapter of CannabisLAB, a networking and education group for professionals who are in or are looking to get involved in the cannabis marketplace.

Dustin Robinson | Managing Partner

DUSTIN ROBINSON

Founding Partner
States Licensed: FL

Dustin Robinson is the Founding Partner of LumaLex Law. Licensed in Florida as an Attorney, Certified Public Accountant, and Real Estate Agent, Robinson brings a rare, fully integrated legal–financial–business perspective to every engagement. His practice focuses on corporate structuring, regulatory strategy, transactions, capital formation, and high-stakes commercial litigation for growth-stage and emerging-market companies across a wide range of industries.

Before launching LumaLex Law, Robinson trained at two of the world’s most respected professional services firms—Deloitte and Holland & Knight—where he developed deep technical grounding in tax, corporate law, and complex commercial matters. He then left traditional practice to become an operator himself, applying his legal and accounting background to help run a multi-state manufacturing company that he helped grow to nearly $50 million in revenue. That experience shaped his core philosophy: great legal advice must be practical, entrepreneurial, and grounded in the realities of building and scaling real businesses.

Robinson is not only an advisor to entrepreneurs—he is one. In addition to LumaLex Law, he is the founder of multiple ventures, including Iter Investments , a venture capital fund backing frontier technologies and next-generation healthcare platforms; and Nucleus, a venture studio focused on launching digital and data-driven assets in emerging markets. Across his legal and investment platforms, Robinson has worked with founders operating in biotech, neurotech, telehealth, psychedelics, cannabis, fintech, real estate, digital media, AI-driven platforms, and other highly regulated or rapidly evolving sectors.

Widely regarded as a trailblazer in emerging industries, Robinson has played a leading role in shaping legal and commercial frameworks for novel business models long before they became mainstream. He has served as lead counsel in several high-profile commercial disputes, including the widely covered Shohei Ohtani 50–50 baseball litigation, and is frequently sought out for matters involving regulatory gray zones, innovative deal structures, and first-of-their-kind ventures.

Robinson also served on the Board of Directors of Clairvoyant Therapeutics, a biotechnology company that was advancing psilocybin-based treatments for alcohol use disorder through FDA clinical trials. He has advised and represented numerous venture-backed companies, founders, and investment vehicles operating at the intersection of science, technology, regulation, and capital markets.

Beyond legal practice and investing, Robinson is deeply involved in thought leadership and ecosystem-building. He created and moderates a long-running monthly panel series at Soho Beach House Miami, convening founders, physicians, scientists, investors, and cultural leaders to discuss innovation, wellness, and frontier technologies. Past guests have included NBA Champion Lamar Odom, NHL star Daniel Carcillo, and other prominent figures across business and entertainment.

Robinson has been regularly profiled and featured as an expert in major media outlets, including Bloomberg News, Forbes, The Wall Street Journal, INSIDER, VICE, The Miami Herald, Authority Magazine, Thrive Global, Benzinga, and others. He is a frequent speaker at global industry conferences and private founder and investor forums.

A triple Gator, Robinson earned his Bachelor’s in Accounting, Master’s in Accounting, and Juris Doctor from the University of Florida.

Today, Robinson’s work sits at the intersection of law, entrepreneurship, and capital formation. He is known for helping founders think bigger, structure smarter, and move faster—while staying compliant, investable, and defensible. His mission is simple: to help entrepreneurs build category-defining companies in industries that don’t yet have a playbook.